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Macular DegenerationNCT01756248

EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

An observational study of Macular Degeneration, run by Bayer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD). The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice. Read more about this study

Who is it for?
Any age
Conditions the study is for
Macular Degeneration
What is being tested?
Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
How many people
3,872 participants
Where
1 siteJapan
Study dates
26 Dec 2012to 20 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with subfovear choroidal neovascular age-related macular degeneration

Who may be able to join

  • Patients who received EYLEA for AMD

Who cannot join

  • Patients who have already received EYLEA

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Multiple Locations

Other trials in Japan

About this study

Official title: Special Drug Use Investigation of EYLEA for AMD

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD).

The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice.

A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Being tested
Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Keywords
EYLEA, Age-Related Macular Degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)Drug

    Patients treated with EYLEA under practical manner for AMD.

Study groups in NCT01756248
Study groupRoleWhat they receive
Group 1Not described
Receives: Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA

    Measured: Up to 3 years

  2. Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA

    Measured: Up to 3 years

  2. Mean changes in visual acuity

    Measured: Baseline and 6, 24 or 36 months

  3. Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline)

    Measured: Up to 3 years

  4. Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments

    Measured: Baseline and 6, 24 or 36 months

  5. Number and intervals of ITV injection of EYLEA

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2012 (estimated)
  2. Study start26 Dec 2012
  3. Primary completion31 Dec 2018
  4. Study completion20 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756248
Sponsor's protocol ID
15895
Other IDs
EYL-AMD
Status last verified
Jun 2023
First submitted
20 Dec 2012
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ozawa Y, Ohgami K, Sasaki K, Hirano K, Sunaya T. Long-term surveillance provides real-world evidences of safety and effectiveness in intravitreal aflibercept treatment for age-related macular degeneration. Sci Rep. 2023 Jun 30;13(1):10597. doi: 10.1038/s41598-023-37584-1.

    PubMed 37391547

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Degeneration, run by Bayer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01756248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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